Laser Assisted Wound Healing Protocol and System

ABSTRACT

The present invention provides for devices and methods of treating wounds, including general wounds, gum disease and gingival tissues post scaling/root planning, using a diode laser which generates a beam of light having a wavelength in the visible portion of the electromagnetic spectrum (400 nm-700 nm). Further disclosed are devices and methods capable of stimulating tissue regeneration at the site of a wound.

CROSS REFERENCES

This application is an International Application claiming priority toU.S. patent application Ser. No. 15/811,651 filed Nov. 13, 2017, whichis a Continuation-In-Part Application claiming the benefit of priorityfrom U.S. patent application Ser. No. 15/348,793 filed Nov. 10, 2016,the entire contents of which are herein incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to a method of treating gumdiseases using a diode laser which produces a beam of light having awavelength in the visible portion of the electromagnetic spectrum (400nm-700 nm). Optionally, the laser light utilizes green wavelength range(520-570 nm) at a laser power 0.001 W to 5 W to treat wounds. It is alsocontemplated that described is a method of treating diseased soft orhard tissue using a diode laser. Optionally, the laser light utilizesthe IR wavelength range (700 nm-1400 nm) at a laser power of 0.001 W to5 W to treat wounds. Optionally, an LED light utilizes the IR wavelengthrange to treat wounds.

BACKGROUND OF THE INVENTION

Laser Assisted Periodontium and Osseous Regeneration (LAPOR) is aprotocol which is laser assisted with the use of a substrate such as butnot limited the LAPOR periodontal solution, the LAPOR periodontal geland the LAPOR substrate and thus causes an increase in cell attachmentof epithelial cells, gingival fibroblasts, PDL fibroblasts and adhesionof osteogenic cells. Enhanced cell migration and proliferation appearsto lead to accelerated wound fill rates in vitro using PDL fibroblasts,gingival fibroblasts and osteoblast-like cells.

A substrate such as the LAPOR periodontal solution, the LAPORperiodontal gel and the LAPOR substrate, used in the LAPOR protocol,stimulates total protein synthesis and the synthesis of specificextracellular matrix molecules. Studies that evaluate the boneremodeling regulation system indicate that proteins influence thisregulation system, thus indicating an indirect involvement in the boneremodeling process. When used in conjunction with a specially formulatedperiodontal and wound healing substrate or combination of substrates,and LAPOR gel root conditioner in certain cases, LAPOR has shown tostimulate total tissue and bone synthesis, increase gingival attachment,gingival height, bone density, bone height thereby showing acceleratedwound fill rates in vivo.

The laser or LED used produces a beam of light having a wavelength inthe visible portion of the electromagnetic spectrum (400 nm-700 nm).Optionally, a beam of light having a wavelength in the green wavelengthrange (520-570 nm) at a laser power of 0.5 to 1.2 W is used in the LAPORprotocol. It has been shown by the LAPOR protocol to biostimulate thehealing and regenerative processes of the periodontium, including thebiostimulation of new bone and its supporting elements. The diode laserused in the LAPOR protocol, biostimulates the healing response of theperiodontium, and biostimulates the soft or hard tissue regeneration ofthe periodontium, and prevents long junctional epithelium from migratingdownwards into the sulcus (a biomechanical aspect of tissue healing),thereby preserving the tissue height. A diode laser used in the LAPORprotocol helps a substrate such as but not limited to compounds andproteins to stimulate total protein synthesis and the synthesis ofextracellular matrix molecules.

Alternatively, the LAPOR protocol may use a beam of light having awavelength in the green wavelength range (520-570 nm), red wavelengthrange (620-750 nm), or yellow wavelength range (570-590 nm) having analternative wattage of 0.001 W to 5 W, preferably 0.002 W to 4 W, morepreferably 0.003 W to 4 W, and most preferably 0.005 W to 2 W. The diodelaser used helps the substrate(s) stimulate total tissue and bonesynthesis by biostimulating the healing response via soft/hard tissueregeneration of a wound and soft/hard tissue regeneration of the wound'ssupporting elements.

It is further contemplated that the invention may be used to treat softand/or hard tissue damage in wounds, i.e. Laser Assisted Tissue andOsseous Regeneration (LATOR) using a LATOR solution, and/or LATOR geland/or a LATOR substrate or a combination of substrates to enhance cellmigration and proliferation leading to accelerated wound fill rates. Theprotocol is used in conjunction with a choice or any combination of sixspecially formulated tissue and wound healing substrates and a gelconditioner in certain cases to stimulate total tissue and bonesynthesis, increase tissue attachment, tissue height, bone density andbone height thereby showing accelerated would fill rates, showing amechanism of action as in the LAPOR protocol.

SUMMARY OF THE INVENTION

In an exemplary embodiment of the present invention, there is discloseda method of treating wounds, including general wounds, gum disease andgingival tissues post scaling/root planning, using a diode laser whichgenerates a beam of light having a wavelength in the visible portion ofthe electromagnetic spectrum (400 nm-700 nm). Optionally, a beam oflight having a wavelength in the green range (520-570 nm) at a laserpower of 0.5 to 1.2 watts is used to decontaminate the wound or gumtissue and to biostimulate healing while regenerating the wound orperiodontium (including cementum of the root surface and/or tissuessurrounding an implant), thus preventing long junctional epithelium frommigrating downwards into the sulcus and thereby preserving the tissueheight. Alternatively, a beam of light having a wavelength in the greenwavelength range (520-570 nm), red wavelength range (620-750 nm), oryellow wavelength range (570-590 nm) having an alternative wattage of0.001 W to 5 W may be used to biostimulate healing and regenerate thewound site, its tissue and bone. In a preferred embodiment, the wattageis in the range of 0.002 W to 4 W, more preferred in the range of 0.003to 3 W, and most preferred in the range of 0.005 W to 2 W. A laser orLED also biostimulates the healing and regenerative response induced bya substrate, i.e. the LAPOR periodontal and wound healing solution, theLAPOR periodontal gel and the LAPOR periodontal and wound healingsubstrates, the method comprising: 1) placing the laser inside thesulcus; 2) penetrating the entire sulcus by moving the laser lightintermittently vertically and horizontally throughout the sulcus; and 3)placing the substrate in the sulcus prior to blood clot formation. In apreferred embodiment, the LATOR protocol may use a laser per the aboveparameters to treat general wound sites. Optionally, the laser lightutilizes the IR wavelength range (700 nm-1400 nm) at a laser power oraverage power of 0.001 W to 5 W to treat wounds.

In an alternative embodiment, the LAPOR or LATOR protocol may use an LEDlight to biostimulate healing and to regenerate periodontium or generalwound tissue. The LED light is used at 10 W or, preferably, 9 W or loweron wounds to assist in new cell organization and hence tissueregeneration. Optionally, an LED light utilizes the IR wavelength rangeto treat wounds. Optionally, the laser light utilizes the IR wavelengthrange (700 nm-1400 nm) at a laser power of 0.001 W to 5 W to treatwounds.

In an alternative embodiment, the LAPOR and LATOR protocols may use aradiofrequency (RF) wave to decrease pain or decontaminate the gumtissue and biostimulate healing while regenerating the periodontium andwound. The RF beam is used at 10 W or, preferably, 9 W or lower onwounds to assist in new cell organization and hence soft and/or hardtissue regeneration. A carrier wave (sine wave) transports anon-sinusoidal waveform or waveforms to the treatment location. Thecarrier wave frequency may be in the range of 0.1 MHz to 20 MHz whilethe non-sinusoidal waveform may be in the range of 0.5 to 40 KHz oralternatively 0.5-24 GHz. In a preferred embodiment, the carrier wavefrequency is in the range of 0.2 MHz to 10 MHz, preferably 0.3 MHz to 5MHz. Optionally the 0.001 W to 10 W or 9 W range, preferably a 0.001 Wto 3 W range, is utilized in the hertz range of 40 Hz to 24 GHz. In afurther alternative embodiment, the RF wave is a single sine wave. In afurther alternative embodiment, the RF wave is more than one sine wavewherein the more than one demonstrates a harmonics pattern. In apreferred embodiment, the LATOR protocol may use an RF wave per theabove parameters to treat general wound sites. Optionally, thenon-sinusoidal waveform/s may be in the range of the above parameters inthe absence of a carrier wave.

In another embodiment of the present invention, there is disclosed aroot/bone/cartilage gel conditioner comprised of EDTA 15%, calciumgluconate 20%, methylparaben, propylparaben, Ethanolamine as a bufferingagent, carboxymethylcellulose, and green food coloring and sterilewater.

In still another embodiment of the present invention, there is discloseda first substrate comprised of: a combination of mono or disodiumphosphate and sodium hydroxide in solution with a sodium content of 11mg/100 g; 60% water; 9% Lysine; 9% Proline; 9% all other essential aminoacids wherein the amino acids are chosen from the group consisting ofIsoleucine, Leucine, Methionine, Phenylalanine, Threonine, Tryptophan,Valine, Histadine, Asparagine and Selenocysteine; 2% of all othernon-essential amino acids wherein the amino acids are chosen from thegroup consisting of Alanine, Arginine, Aspartate, Cysteine, Glutamate,Glutamine, Glycine, Serine, Tyrosine and Pyrrolsine; 6.9% free baseswherein the free bases are chosen from the group consisting ofadenosine, uridine, guanosine, iridin and cytidine; 2% phosphateswherein the phosphates are chosen from the group consisting of ADP, ATPand acetycholine; and 1% benzoic acid.

In still another embodiment of the present invention, there is discloseda second substrate comprised of: tricalcium phosphate wherein thetricalcium phosphate is precipitated with calcium hydroxide/Claw oil;and hydroxyapatite crystals Optionally, the second substrate iscomprised of tricalcium phosphate wherein the tricalcium phosphate isprepared with hydroxyapatite crystals, wherein the second substrate iscomprised of dense or porous tricalcium phosphate comprising of one sizeor variety of sizes of crystals: 4-50 μm, 50-150 μm, 100-300 μm,500-1000 μm, 1-3 mm, and 3-6 mm.

In yet another embodiment of the present invention, there is disclosed athird substrate comprised of: 5.1% hyaluronic acid; 8% fatty acidswherein the fatty acids are chosen from the group consisting of Linoleicacid (LA), alpha-linolenic acid (ALA), 4.4% sugars wherein the sugarsare chosen from the group consisting of mannose, galactose,N-acetylglactosamine, N-acetylglucosamine, N-acetylneuraminic acid,fucose (L configuration minus a carboxyl group at the 6 position), andxylose; 2.2% mixture of glucose and fucose (L configuration minus acarboxyl group at the 6 position); 3% lipids wherein the lipids arechosen from the group consisting of vitamin A, vitamin D2, D3, vitaminE, vitamin K1, K2, vitamin B12 (methylcobalamin, hydroxocobalamin),cholesterol, and diaglycerol; 2.7% vitamins wherein the vitamins arechosen from the group consisting of vitamin B1, vitamin B2, vitamin B3,vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin C andpantothenic acid; 4.5% electrolyte sources: wherein the electrolytesources are chosen from the group consisting of Calcium Chloride,Choline Chloride, Magnesium Sulfate, Potassium Chloride, PotassiumPhosphate (monobasic), Sodium Bicarbonate, Sodium Chloride, and SodiumIodide; 6% metals wherein the metals are chosen from the groupconsisting of Ag nanoparticles and Au nanoparticles; 3.9% ionic metalswherein the ionic metals are chosen from the group consisting of copper,zinc, selenium, iron, manganese, cobalt, chromium, boron, andmolybdenum; and 4% other ionic metals wherein the other ionic metals arechosen from the group consisting of boron, silicon, nickel and vanadium.

In another embodiment of the present invention, there is disclosed afourth substrate comprised of carbomer, potassium chloride, chloride,sodium, potassium, manganese, calcium tri-phosphate, sulfate, carbonate,snail serum, snail secretion filtrate, HA, Au, Ag, Cu, Fe, Pt, collagen,glyceine HCl and fucose.

In another embodiment of the present invention, there is disclosed asfifth substrate comprised of a dense or porous tricalcium phosphate in avariety of crystal sizes, and/or collagen limed and/or collagen unlimed.

In another embodiment of the present invention, there is disclosed asixth substrate comprised of a dense or porous tricalcium phosphate in avariety of crystal sizes, and/or collagen limed and/or collagen unlimedand/or HCl and/or NaCl, and/or nanoparticles wherein the nanoparticlesare chosen from the group consisting of copper, Au, Ag, iron, Fe₃O₄, andplatinum or any combination thereof and/or compounds wherein thecompounds are chosen from the group consisting of CuCl₃, CuCl₂, CuCl,FeCl₃, FeCl₂, AuCl, AuCl₂, AuCl₃, AgCl, AgCl₂ or any combinationthereof, and/or Hyaluronic Acid and/or dense or porous hydroxyapatite ina variety of crystal sizes.

The more important features of the invention have thus been outlined inorder that the more detailed description that follows may be betterunderstood and in order that the present contribution to the art maybetter be appreciated. Additional features of the invention will bedescribed hereinafter and will form the subject matter of the claimsthat follow.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and the arrangements of the componentsset forth in the following description or illustrated in the drawings.The invention is capable of other embodiments and of being practiced andcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein are for the purpose ofdescription and should not be regarded as limiting.

As such, those skilled in the art will appreciate that the conception,upon which this disclosure is based, may readily be utilized as a basisfor the designing of other structures, methods and systems for carryingout the several purposes of the present invention. It is important,therefore, that the claims be regarded as including such equivalentconstructions insofar as they do not depart from the spirit and scope ofthe present invention.

The foregoing has outlined, rather broadly, the preferred feature of thepresent invention so that those skilled in the art may better understandthe detailed description of the invention that follows. Additionalfeatures of the invention will be described hereinafter that form thesubject of the claims of the invention. Those skilled in the art shouldappreciate that they can readily use the disclosed conception andspecific embodiment as a basis for designing or modifying otherstructures for carrying out the same purposes of the present inventionand that such other structures do not depart from the spirit and scopeof the invention in its broadest form.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aspects, features, and advantages of the present invention willbecome more fully apparent from the following detailed description, theappended claim, and the accompanying drawings in which similar elementsare given similar reference numerals.

FIG. 1 shows an X-Ray view of a patient's teeth before treatment with adiode laser before a substrate has been applied.

FIG. 2-7 show X-Ray views of the lower teeth of FIG. 1 after treatmentwith a diode laser after treatment with a substrate.

FIG. 8 shows an X-Ray view of the upper teeth before treatment with adiode laser after treatment with a substrate.

FIG. 9 shows an X-ray view of the upper teeth of FIG. 8 after treatmentwith a diode laser after treatment with a substrate.

FIG. 10 shows a flow diagram of a method of using a diode laser to treatgum disease in accordance with the principles of the invention.

FIG. 11 shows bone density measurements for tooth 15 of a patient at 12loci on the tooth following treatment with a diode laser and a substrateover time.

FIG. 12 shows bone density measurements for tooth 28 of a patient at 17loci on the tooth following treatment with a diode laser and a substrateover time.

FIG. 13 shows bone density measurements for tooth 2, tooth 3 and tooth15 of a patient at 3 loci per tooth following treatment with a diodelaser and a substrate over time.

FIGS. 14a and 14b show X-rays of tooth 15 of a patient from whichmeasurements shown in FIG. 11 were collected. (a) shows tooth 15 beforetreatment. (b) shows tooth 15 at the October 2011 measurement followingthree treatments.

FIGS. 15a and 15b show X-rays of tooth 28 of a patient from whichmeasurements shown in FIG. 12 were collected. (a) shows tooth 28 beforetreatment. (b) shows tooth 28 at the January 2011 measurement followingfour treatments.

FIGS. 16a and 16b show a panoramic X-ray of tooth 2, tooth 3 and tooth15 of a patient from which measurements shown in FIG. 13 were collected.(a) shows the teeth before treatment. (b) shows the teeth at the July2011 measurement.

FIG. 17a-17f show various views of a first embodiment of a diode laserwith RF of the present invention. (a) shows a right side view. (b) showsa back side view. (c) shows a left side view. (d) shows a front sideview. (e) shows a top view. (f) shows a bottom view.

FIG. 18a-18c show an exploded view of the diode laser of FIG. 17. (a)shows an exploded view. (b) shows an assembled view. (c) shows aclose-up of the laser housing.

FIG. 19a-19g shows various views of a second embodiment of the RF devicewithout diode laser of the present invention. (a) shows a topperspective view. (b) shows a back view. (c) shows a left side view. (d)shows a top view. (e) shows a front perspective view. (f) shows a rightside view. (g) shows a bottom view.

FIG. 20a-20d shows views of the RF device with and without diode laserof FIG. 19. (a) shows an exploded view of RF device with laser. (b)shows a close-up of the handpiece with laser relative to housing. (c)shows an exploded view of RF device without laser. (d) shows detailedview of housing for RF device without laser.

FIG. 21a-21f show various views of a third embodiment of the RF deviceof the present invention, with and without the laser. (a) shows a sideperspective view. (b) shows an exploded view of the RF device withlaser. (c) shows a close-up view of the laser relative to thesub-housing. (d) shows a side perspective view. (e) shows an explodedview of the RF device without laser. (f) shows a detailed view of thesub-housing within the RF device without laser.

FIG. 22a-22h shows fiber optic handpiece and tip embodiments of thepresent invention, along with the power device and battery embodimentsfor the handpieces. (a) shows an assembled view. (b) shows an explodedview. (c) shows a flat tip. (d) shows a glass dispersion tip. (e) showsan assembled view of the power device. (f) shows an exploded view of thepower device. (g) shows an assembled view of the battery pack. (h) showsan exploded view of the battery pack.

FIG. 23a-g shows flow charts of the protocol embodiments for using an RFdevice of the present invention, along with placement instrumentembodiments for applying the preferred substrates of the presentinvention. (a) flow chart of the protocol along with certain parameters.(b) a preferred flow chart with preferred parameters. (c)-(e) oralsurgery placement instruments. (f)-(g) periodontal placementinstruments.

FIG. 24 shows chin profile measurements before and after treatment.

FIG. 25 shows toe crease length measurements before and after treatment.

FIG. 26a-26c show gingival wound healing and tissue regenerationmeasurements before and after treatment. (a) shows wounds beforetreatment. (b) shows tissue regeneration after treatment. (c) showstissue height measurements before and after treatment.

FIG. 27 shows hand crease length measurements before and aftertreatment.

FIG. 28 shows wound new skin growth measurements before and aftertreatment.

FIG. 29 shows (anal) scar width reduction measurements before and aftertreatment.

FIG. 30 shows (anal) scar length reduction measurements before and aftertreatment.

FIG. 31 shows swallowing strength measurements before and aftertreatment.

FIG. 32 shows breast firmness measurements before and after treatment.

FIG. 33a-33e show various views of an RF hand piece of the presentinvention. (a) shows a top view. (b) shows a side view. (c) shows aperspective view of the RF tips. (d) shows an exploded side perspectiveview. (e) shows an alternative side perspective view.

FIG. 34a-34f show various views of a fourth alternative diode laser ofthe present invention. (a) shows a right side view. (b) shows a frontview. (c) shows a left side view. (d) shows a left side perspectiveview. (e) shows a top view. (f) shows a right side perspective view.

FIG. 35 show various views of a laser power source for the fiber optichand piece and interchangeable tips.

FIG. 36a-36f shows various views of a portable RF transmitter of thepresent invention. (a) shows a top view. (b) shows a front view. (c)shows a bottom view. (d) shows a left side view. (e) shows a left frontperspective view. (f) shows a right front perspective view.

FIG. 37 shows epithelial wound regeneration before and after treatment.

FIG. 38 shows cancaeal tendon wound regeneration before and aftertreatment.

FIG. 39 shows ankle epithelial wound regeneration before and aftertreatment.

FIG. 40 shows ankle wound size reduction before and after treatment.

FIG. 41 shows oral cavity wound regeneration before and after treatment.

FIG. 42a-b shows (a) vein wound regeneration before and after treatmentand (b) a flashlight style infrared laser.

FIG. 43a-b shows increases in tissue regeneration in (a) epithelialtissue and (b) oral cavity wound.

DETAILED DESCRIPTION OF THE INVENTION Definitions

As used herein, the term “gum disease” means periodontal disease whichcan lead to tooth loss and/or other health problems. Examples ofperiodontal disease include gingivitis, aggressive periodontitis,chronic periodontitis, periodontitis as a manifestation of systemicdiseases, and necrotizing periodontal disease.

As used herein, the term “tissue disease” means soft or hard tissuedisease of acute or chronic nature which can lead to other healthproblems such as amputation of limbs.

As used herein, the term “patient” means any individual suffering from adisease of the gums or tissue and in need of treatment for said gum ortissue disease.

As used herein, the term “locus” means an exact point of measurementwithin the sulcus or the immediate surrounding area.

As used herein, the term “substrate mixture” means the mixture of thefirst substrate and/or the second substrate and/or the third substrateand/or the fourth substrate and/or the fifth substrate and/or sixthsubstrate disclosed herein for treatment of gum disease and/or tissuedisease and/or wounds.

As used herein, the term “substrate” means any stand alone substrate ofthe substrates disclosed herein for treatment of gum disease and/ortissue disease and/or wounds.

As used herein, the term “bone regeneration” means increasing thedensity of calcium at specific loci in or around the sulcus or theimmediate surrounding area.

As used herein, the term “calcium density” means the measurement ofcalcium mass around a given loci.

As used herein the term “wound” means any area that has lost anyoriginal tissue or bone or any other structure not named that lost ahealthy non-wounded, undamaged and unaged form.

As used herein, the terms “power” and “average power” are consideredsynonymous, with “power” referring to continuous power applied tolasers, LEDs or RF devices while “average power” refers to pulsed powerapplied to lasers, LEDs or RF devices of the present invention.

As used herein, the terms “laser” or “LED” or “RF” mean types of energyand may be used with or without substrate.

The LAPOR protocol can be used in the treatment of gum disease andwounds by combining the most effective methods of treatment with the useof a special laser. Approximately 66% of the United States populationhas some form of gum disease. But many avoid seeking treatment becauseof the discomfort that often results from gum surgery. LAPOR provides anew choice. The LAPOR protocol is a treatment that is more effectivethan traditional periodontal surgery, and it is much more beneficial tothe patient both in the short and long term. The LATOR protocol cansimilarly be used for treatment of soft or hard tissue disease andwounds.

The LAPOR protocol takes only about an hour and only two short follow-upvisits. Patients enjoy no downtime with recovery taking only 24 hours.This makes immediate return to work both possible and comfortable.

After having the LAPOR protocol performed, no resulting gum recessionoccurs is zero when compared to that which most often follows normalperiodontal surgery. This, combined with new cementum formation on theroots, bone formation in previous defects or around failing implants,periodontal ligament formation. After having the LATOR protocolperformed in a chronic wound, no resulting subsequent wound fibrosis isfound compared to that which most often follows normal treatment, newsoft and/or hard tissue formation occurs multi directionally and thewound closes without grafting.

The LAPOR and LATOR protocols of the present invention can be used toheal wound sites by combining or using separately the most effectivemethods of treatment with the laser, LED, radiofrequency energy andsubstrates. In a preferred embodiment, the RF energy waves may be up to10 W, with most preferably being only as high as 9 W. The carrier wavefrequency may be in the range of 0.1 MHz to 20 MHz while thenon-sinusoidal waveform/s may be in the range of 0.5 to 40 KHz or from0.5 to 24 GHz. In a preferred embodiment, the carrier wave frequency isin the range of 0.2 MHz to 10 MHz, preferably 0.3 MHz to 5 MHz.Optionally a 0.001 W to 10 W range RF energy, preferably a 0.001 W to 3W range, is utilized in the hertz range of 40 Hz to 24 GHz. In a furtheralternative embodiment, the RF wave is more than one square wave whereinthe more than one may demonstrate a pattern. In a further alternativeembodiment, the RF wave is more than one sine wave wherein the more thanone demonstrates a harmonics pattern.

The special type of laser used in the LAPOR protocol and the LATORprotocol is the diode, a semiconductor coherent light beam. The laser orLED light used has a wavelength in the visible portion of theelectromagnetic spectrum, between 400 nm-700 nm wavelength. Optionally,the green range (520-570 nm) of the visible spectrum is utilized at alaser power or average power of 0.5 to 1.2 watts, which disinfects thesite, leaving the gum tissue bacteria free, and biostimulates healing;in conjunction with treatment with a substrate, the laser biostimulatesregeneration of the periodontium. Traditional periodontal therapyremoves tissue height of a tooth or implant to reduce the pocket depths.The LAPOR protocol is a regenerative procedure. The patient does notlose tissue volume. Tissue volume is increased and bone is regenerated.For general tissue disease, the laser biostimulates regeneration oftissue where traditional therapy removes tissue height to reduce thedisease. Optionally, the laser light utilizes the IR wavelength range(700 nm-1400 nm) at a laser power or average power of 0.001 W to 5 W totreat wounds. Optionally, each LED light is used at 10 W or, preferably,9 W or lower.

The use of the diode laser in conjunction with routine scaling and rootplanning is more effective than scaling and root planning alone. Itenhances the speed and extent of the patients gingival healing andpostoperative comfort. This is accomplished through laser bacterialreduction and biostimulation with a laser light having a wavelength inthe visible portion of the electromagnetic spectrum, between 400 nm-700nm wavelength. Optionally, the green range (520-570 nm) of the visiblespectrum is utilized at a laser power or average power of 0.5 to 1.2watts. Alternatively, the laser power wattage may be in the range of0.001 W to 5 W, preferably 0.002 W to 4 W, more preferably 0.003 W to 3W, and most preferably 0.005 W to 2 W.

Referring to FIG. 10, there is disclosed a method 10 of using a diodelaser which produces a beam of light, used intermittently, having awavelength in the visible portion of the electromagnetic spectrum,between 400 nm-700 nm wavelength. Optionally, the green range (520-570nm) of the visible spectrum is utilized at a laser power of 0.5 to 1.2watts to treat gum disease. Starting at block 12, a perio probedetermines the degree of excessive pocket depth and thus helps thedentist better identify diseased soft and hard tissue and areas ofbacterial infection. The dentist removes calculus from the root orimplant surface using an ultrasonic scaler and hand instruments, block14. This action by the dentist helps stimulate a healing response in thesulcus by opening the capillaries upon scaling. Going to block 18, thelaser tip is placed inside the sulcus and a continuous light beam withintermittent stops for tissue temperature control is allowed topenetrate the entire sulcus by moving the tip vertically andhorizontally throughout the sulcus. The laser tip is cut at a 45 degreeangle during the first pass. The laser is cut at the opposite 45 degreeangle during the second pass. This allows for the laser beam topenetrate the existing periodontium to decontaminate the tissue, as theheat of the targeted laser light kills the bacteria. This also allowsfor biostimulation of the sulcular contents. At block 20, the dentistscales the sulcular area and root/implant surfaces once again to inducea healing response through renewed blood flow. Going to block 22, atleast one substrate, such as but not limited to matrix proteins, is thenplaced in the sulcus of the tooth prior to the blood clot forming and atblock 24, a blood clot is carefully allowed to form by gently helpingpatient keep their mouth open for 5 minutes, to keep the substrateintact. Optionally, the laser light utilizes the IR wavelength range(700 nm-1400 nm) at a laser power of 0.001 W to 5 W to treat wounds.

Alternatively, the laser tip is a specially designed tip that disperseslight energy throughout the wounded sulcus which allows the laser beamto penetrate the existing tissues to decontaminate the tissue, as theheat of the targeted laser light kills the bacteria and as a resultblock 20 may be eliminated going directly to block 22

The LAPOR protocol is much less invasive than traditional surgery andoffers advantages and benefits over its counterpart. Recovery time ismuch faster because most, if not all, damage to healthy tissue isavoided through the use of more advanced technology. Because the LAPORprotocol leaves healthy tissue intact, the height of the gums themselvesincreases around the teeth and is better preserved. The LAPOR protocolprevents long junctional epithelium from migrating downwards into thesulcus, thus preserving the tissue height and allowing for theregeneration of the periodontium.

Referring to FIG. 17a-17f , shown are various angles of the firstembodiment of a device 100 for use in conjunction with the substratesand methods of the present invention. FIGS. 18a and 18b show perspectiveviews of the device 100 in the first embodiment. Specifically, FIG. 18aillustrates an exploded view of the device 100 comprised of cord 101integrally connected to handle 109, handle 109 further connected to heatsink 102. Housing 103 securely connects to heat sink 102 therebycreating a cavity between the housing 103 and heat sink 102. Laser 104is positioned within the cavity between housing 103 and heat sink 102.Male connectors 105 connect RF source 108 to housing 103 whereinthreaded inserts 106 cover the connection therebetween. Cap 107 ispositioned over housing 103 and secures to handle 109. FIG. 18c shows adetailed view of heat sink 102, laser 104, housing 103 and maleconnectors 105 in relation to each other. In a preferred embodiment, thedevice 100 may have a plurality of RF sources 108 wherein a plurality isdefined as at least two tips (i.e. dipole). Housing 103 is capable ofmovement such that RF source 108 may be adjusted 45° up or down relativeto the x-axis for ease of use depending upon the location of the woundreceiving treatment.

The laser energy may have wavelength in the green wavelength range(520-570 nm), red wavelength range (620-750 nm), or yellow wavelengthrange (570-590 nm) having a wattage of 0.001 W to 5 W. In a preferredembodiment, laser energy has a wattage of 0.001 W to 5 W. The wattage isin the range of 0.001 W to 4 W, more preferred in the range of 0.003 to3 W, and most preferred in the range of 0.005 W to 2 W. The RF energymay have a power of 9 watts or lower. The carrier wave frequency may bein the range of 0.1 MHz to 20 MHz while the non-sinusoidal waveform maybe in the range of 0.5 to 40 KHz or from 0 to 24 GHz. In a preferredembodiment, the carrier wave frequency is in the range of 0.2 MHz to 10MHz, preferably 0.3 MHz to 5 MHz. Optionally a 0.001 W to 10 W range RFenergy, preferably a 0.001 W to 3 W range, is utilized in the hertzrange of 40 Hz to 24 GHz. In a further alternative embodiment, the RFwave is more than one sine wave wherein the more than one demonstrates aharmonics pattern. Optionally, the non-sinusoidal waveform may be singleor multiple and in the range of the above parameters in the absence of acarrier wave.

Referring to FIG. 19a-19g , shown are various angles of a secondembodiment of a device 200 for use in conjunction with the substratesand methods of the present invention. FIG. 20a shows a perspective viewof the device 200 of the second embodiment. Specifically, FIG. 20aillustrates an exploded view of the device 200 comprised of wire grommet201 integrally connected to handle 209, handle 209 further comprised ofheat sink 202. Housing 203 securely connects to heat sink 202 therebycreating a cavity between the housing 203 and heat sink 202. Laser 204is positioned within the cavity between housing 203 and heat sink 202.Male connectors 205 connect RF source 208 to housing 203 whereinthreaded inserts 206 cover the connection there between. FIG. 20b showsa detailed view of laser 204 and housing 203 in relation to each other.

Referring to FIG. 21a-21c , shown is a third embodiment of a device 300for use in conjunction with the substrates and methods of the presentinvention. FIG. 21a shows a perspective view of the device 300 of thesecond embodiment. Specifically, FIG. 21b illustrates an exploded viewof the device 300 having an external housing 307 and further comprisedof wire grommet 301 integrally connected to sub-housing 303, sub-housing303 further comprised of heat sink 302. Sub-housing 303 securelyconnects to heat sink 302 thereby creating a cavity between thesub-housing housing 303 and heat sink 302. Laser 304 is positionedwithin the cavity between sub-housing housing 303 and heat sink 302.Male connectors 305 connect RF tips 308 to sub-housing housing 303wherein threaded inserts 306 cover the connection there between. FIG.21c shows a detailed view of laser 304 and sub-housing housing 303 inrelation to each other. By way of example only, the device may have fiveor six tips.

Referring to FIG. 21d-21f , shown is a third embodiment of a device 300for use in conjunction with the substrates and methods of the presentinvention. FIG. 21d shows a perspective view of the device 300 of thesecond embodiment. Specifically, FIG. 21e illustrates an exploded viewof the device 300 comprised of wire grommet 301 integrally connected tosub-housing 303, sub-housing 303 further comprised of heat sink 302.Sub-housing 303 securely connects to heat sink 302 thereby creating acavity between the sub-housing 303 and heat sink 302. RF tips 308 arepositioned within the openings in close proximity to sub-housing 303.Male connectors 305 connect RF source 308 to sub-housing 303 whereinthreaded inserts 306 cover the connection there between. FIG. 21f showsa detailed view sub-housing 303. By way of example only, the device mayhave five or six tips.

Referring to FIGS. 22a and 22b , shown is a fiber optic device 400 foruse in conjunction with the substrates and methods of the presentinvention. Fiber optic device 400 is comprised of hand grip assembly 401disposed between a first end and a second end. The first end is furthercomprised of nose insert 402 positioned between hand grip assembly 401and removable nose assembly 404. Bent fiber tube 405 extends fromremovable nose assembly 405. The second end is further comprised of baseinsert 406 positioned between hand grip assembly 401 and rubber boot407. Extending from rubber boot 407 is sheathed fiber 408 having a SMAconnector 409 at the end opposite rubber boot 407.

Referring to FIG. 22c-22d , shown are alternative embodiments ofinterchangeable fiber optic tips for a laser for use in conjunction withthe substrates and methods of the present invention. FIG. 22c shows aninterchangeable fiber optic tip for a laser having a nose piece 900 anda flat tip 901. FIG. 22d shows an interchangeable fiber optic tip for alaser having a nose piece 900 and a glass dispersion tip 902.

Referring to FIGS. 22e and 22f , shown are preferred embodiments of apower device suitable for accommodating the handpieces of the presentinvention. FIG. 22e shows a complete power device 2201. FIG. 22f showsan exploded view of the power device 2201 of FIG. 22e . The componentsinclude a heatsink 2203 positioned above a heatsink base 2202. A fiberoptic laser 2204 sits above the heatsink 2203, wherein a fiber opticattachment 2205 sits above the fiber optic laser 2204 and is exposedthrough the top 2207 of the device 2201. A battery mount 2206 havingdevice-side charging tips 2209 is positioned in order to accommodate abattery (not shown). A power switch 2208 appears through the top 2207 ofthe device 2201.

Referring to FIGS. 22g and 22h , shown are preferred embodiments of thebattery pack for the power device for the handpieces of the presentinvention. FIG. 22g shows a battery pack 2210. FIG. 22h shows anexploded view of the battery pack 2210, including a base 2211 into whichthe battery 2212 is fitted. The battery 2212 is in contact withbattery-side charging tips 2213 that abut charging housing 2215 througha top 2214 of the battery pack 2210.

Referring to FIGS. 23a-g , shown are flow charts and preferredinstruments for placement of substrate for given procedures. FIGS. 22aand 22b detail specific protocols and certain parameters for operatingthe devices of the present invention. FIGS. 22c-22e detail certainplacement instruments used in oral surgery procedures. FIGS. 22f and 22gdescribe certain placement instruments for use in periodontalprocedures.

Firstly, the conditioner is applied to the root or bone surface. Theroot conditioner comprises the following at Table 1:

TABLE 1 Component EDTA 20-25 g. Calcium gluconate 10-20 g. Methylparaben.1-.9 g. Propylparaben .01-.1 g. Ethanolamine 2-8 mls.Carboxymethylcellulose 2-10 g. Green food coloring 1-2 drops Sterilewater 100 mls.

The conditioner is optionally rinsed out prior to application ofadditional substrates or laser light. Alternatively, the conditioner isleft on the root or bone surface with the laser light being appliedprior to application of any substrate. In an alternative embodiment, theconditioner is left in with only one substrate applied prior toapplication of the laser light. Optionally, the conditioner is left inthe sulcus and substrate is added prior to any application of laserlight.

The placement of the substrate into the sulcus containing luminescedblood enables the luminesced blood to coagulate upon the substrate.

Optionally, the liquid substrate or substrate 1 is comprised of thefollowing, per 1 L of solution, at Table 2:

TABLE 2 % Essential Amino Acids Isoleucine 1.125 Leucine 1.125Methionine 1.125 Phenylalanine 1.125 Threonine 1.125 Tryptophan 1.125Valine 1.125 Histidine 1.125 Lysine 9 Non-Essential Amino Acids Alanine0.25 Arginine 0.25 Aspartate 0.75 Glutamate 0.25 Glycine 0.25 Serine0.25 Proline 9 Phosphates ADP 0.667 ATP 0.667 Acetylcholine 0.667 FreeBases Adenosine 1.725 Uridine 1.725 Guanosine 1.725 Cytidine 1.725Benzoic Acid 1 Sodium 1.1 Chloride Sterile water 60 Total: 100

Optionally, the total sterile water component is adjusted 20% up ordown, depending on the desired viscosity to be achieved.

Optionally, the sterile water component also contains some amount ofHyaluronic Acid.

In an alternative embodiment, the liquid substrate or substrate 1 iscomprised of the following, at Table 3:

TABLE 3 Grams Essential Amino Acids Isoleucine 11.25 Leucine 11.25Methionine 11.25 Phenylalanine 11.25 Threonine 11.25 Tryptophan 11.25Valine 11.25 Histidine 11.25 Lysine 90 Non-Essential Amino Acids Alanine2.5 Arginine 2.5 Aspartate 7.5 Glutamate 2.5 Glycine 2.5 Serine 2.5Proline 90 Phosphates ADP 7-8 ATP 7-8 Acetylcholine 6-7 Free BasesAdenosine 13-14 Uridine 13-14 Guanosine 13-14 Cytidine 13-14 Iridine13-14 Benzoic Acid 20 Sodium .1-.9 Chloride Sterile water   .9-1.2 L

In an alternative embodiment, an additional substrate may be applied,the additional substrate, substrate 2, comprised of dense or poroustricalcium phosphate comprising of one size or variety of sizes ofcrystals: 4-50 μm, 50-150 μm, 100-300 μm, 500-1000 μm, 1-3 mm, and 3-6mm and hydroxyapatite crystals.

In an alternative embodiment, an additional substrate may be applied,the additional substrate, substrate 3, is comprised of the following atTable 4:

TABLE 4 200 mg to 5.1 g Hyaluronic acid Grams Fatty acids Linoleic acid(LA) 4 Alpha-linolenic acid (ALA) 4 8 Sugars (except glucose and fucose)Mannose 0.6 Galactose 0.6 N-acetylgalactosamine 0.6 N-acetylglucosamine0.6 N-acetylneuraminic acid 0.6 Fucose (L config. and no carboxyl at 6position) 0.6 Xylose 0.6 4.2 Glucose 1.1 Fucose (L config. and nocarboxyl at 6 position) 1.1 Lipids A 0.3 D2 0.3 D3 0.3 E 0.3 K1 0.3 K20.3 B12 (Methylcobalamin) 0.3 B12 (Nydroxocobalamin) 0.3 Cholesterol 0.3Diaglycerol 0.3 3.0 Vitamins B1 0.3 B2 0.3 B3 0.3 B5 0.3 B6 0.3 B7 0.3B9 0.3 C 0.3 Pantothenic acid 0.3 2.7 Electrolyte Sources Calciumchloride .5 Choline Chloride .5 Magnesium Sulfate .5 Potassium Chloride.5 Potassium Phosphate-monobasic 1 Sodium Bicarbonate .5 Sodium Chloride.5 Sodium Iodide .5 4.5 Metals Ag nanoparticles 0.3 Au nanoparticles 0.30.6 Iconic metals Copper 0.3 Zinc 0.3 Selenium 0.3 Iron 0.3 Manganese0.3 Cobalt 0.3 Chromium 0.3 Boron 0.3 Molybdenum 0.3 2.7 Other ionicmetals Boron 0.3 Silicon 0.3 Nickel 0.3 Vanadium 0.3 1.2 Benzoic Acid Upto 10.1 Sodium Chloride .1-.9 Sterile water 60-300 ml

Optionally, the total sterile water component is adjusted 20% up ordown, depending on the desired viscosity to be achieved.

In an alternative embodiment, an additional substrate may be applied,the additional substrate, substrate 4, is comprised of the following atTable 5:

TABLE 5 Component Grams Notes carbomer   10-40 For acute wound (see FIG.39) use 10-20 For chronic wound (see FIG. 38) use 25-40 ElectrolytesPotassium chloride 0.5-3 Chloride 0.1-1 Sodium 0.1-1 Potassium 0.1-1Manganese 0.1-1 Calcium tri- 0.5-4 phosphate Sulfate 0.1-1 Bicarbonate0.1-1 Snail serum 50-150 ml; for chronic wounds Snail secretion 50-150mg substrate 6 may be incorporated filtrate (see FIG. 41); decreasesdepending HA   3-6 of volume of substrate 6 Au 0.1-1 Ag 0.1-1 Cu 0.1-1Fe 0.1-1 Pt 0.1-1 Collagen   50-150 fucose 0.5-1 Glyceine HCl   0-0.4

Metals may be increased 50% for chronic wounds (see FIG. 40).

Optionally, the total sterile water component is adjusted 20% up ordown, depending on the desired viscosity to be achieved.

Substrates may have different modalities of delivery, for example;liquid, gel, drops, sprays, injections or intravenous having the sameingredients, as well as sublingual, anal, foam and ointment formulationsor drinkable liquids.

In an alternative embodiment, an additional substrate may be applied,the additional substrate 5 is comprised of the following:

1. collagen, limed and/or

2. collagen, unlimed, and/or

3. collagen, supplemented with porous tricalcium phosphate crystals withone size or variety of sizes: 4-50 μm, 50-150 μm, 100-300 μm, 500-1000μm, 1-3 mm and 3-6 mm. The tricalcium phosphate crystals may be dense orporous. Optionally, substrate 5 may be used in the absence of othersubstrates.

In an alternative embodiment, an additional substrate may be applied,the additional substrate 6 is comprised of the following:

-   -   1. collagen, limed and/or    -   2. collagen, unlimed and/or    -   3. HCl and/or    -   4. NaCl and/or    -   5. Cu, Ag, Fe, Au, Pt or any combination thereof and/or    -   6. Collagen, supplemented with porous tricalcium phosphate        crystals with one size or variety of sizes: 4-50 μm, 50-150 μm,        100-300 μm, 500-1000 μm, 1-3 mm and 3-6 mm. The tricalcium        phosphate crystals may be dense or porous. Optionally, substrate        6 may be used in the absence of other substrates.    -   7. nanoparticles wherein the nanoparticles are chosen from the        group consisting of copper, Au, Ag, iron, Fe₃O₄, and platinum or        any combination thereof and/or    -   8. compounds wherein the compounds are chosen from the group        consisting of CuCl₃, CuCl₂, CuCl, FeCl₃, FeC₁₂, AuCl, AuCl₂,        AuCl₃, AgCl, AgCl₂ or any combination thereof, and/or    -   9. Hyaluronic Acid and/or    -   10. Hydroxyapetite, crystals, dense or porous and in a variety        of crystal sizes.

An additional substrate may be applied, the additional substratecomprised of the following: a mixture of tricalcium phosphate andhydroxyapatite crystals. The tricalcium phosphate is precipitatedprepared with HCL CaOH/devil's claw oil, in a preferred embodiment.Optionally, the additional substrate includes 50% tricalcium phosphateprepared with 50% hydroxyapatite crystals. The tricalcium phosphatecrystals used are granules in the following sizes: 4-50 μm, 50-150 μm,100-300 μm, 500-1000 μm, 1-3 mm and 3-6 mm. The tricalcium phosphatecrystals may be dense or porous.

The additional substrate may be comprised of hydroxyapatite crystals ofgranules containing the following sizes: 10-50 μm, 50-150 μm, 100-300μm, 500-1000 μm, 1-3 mm and 3-6 mm. The hydroxyapatite crystals may bedense or porous.

In the following examples, the conditioner is applied and subsequentlyrinsed out. Optionally, the conditioner is left in the sulcus.

After the conditioner is applied, the sulcus is biostimulated with alaser light. After this occurs, the liquid substrate is applied.Optionally, the additional substrate is applied. For cavities other thanoral cavities, a diluted substrate assists treatment when ingested ortaken via IV is beneficial although not required.

In an alternative embodiment, an optional spray substrate, spray 1, maybe applied, the spray comprised of the following: Au, and/or Ag, and/orCu, and/or Fe, and/or Pt, and sterile water.

In an alternative embodiment, an optional spray substrate, spray 2, maybe applied, the spray comprised of the following: Cl, Na, K, Mg,Phosphate, Sulfate, bicarbonate and sterile water.

The fiber optic device of the present invention is the preferable deviceplaced inside the sulcus for treatment. Optionally more than one fibercan be in the handpiece and each fiber can be of a different wavelengthand different average power. The sulcus or wound may also be treatedwith laser, RF or laser with RF or LED. The remaining disclosedembodiments of the device may be used in wound treatment in conjunctionwith the substrates depending on the wound site and severity of thewound. Substrates disclosed herein may be a form including, but notlimited to, liquid, tablet, enema, gel, injection or foam.

Alternative RF and/or Laser Assisted Wounded Tissue Regeneration:

-   -   1. Optionally scale/root plane;    -   2. Optionally etch root of tooth or implant;    -   3. Rinse with saline water;    -   4. Optionally place tip of laser, LED or RF into or around the        sulcular or any other wound, and turn the laser on for up to 5        seconds or more;    -   5. Repeat step 4 circumferentially vertically and horizontally        around tooth or implant until the entire wound has been        saturated by energy;    -   6. Place Substrate 1, and/or 2, and/or 3, and/or 4 and/or 5        and/or 6 into glass dappen dishes;    -   7. Mix the desired amount of substrate 1, and/or 2 and/or 3        and/or 4 and/or 5 and/or 6 in dappen dish;    -   8. Place the desired mixture into the sulcular wound or wound        where bone/tissue loss occurred;    -   9. Wait a few seconds;    -   10. Place more of the mixture into the sulcular wound where        bone/tissue damage occurred if necessary;    -   11. Wait a few seconds;    -   12. Repeat steps 8 until all defects have been filled;    -   13. Wait 1 minute;    -   14. Optionally place hand piece with its laser and/or RF tip        and/or LED tip, with or without laser, in proximity to the        wound, turn on and keep in position for 1 minute;    -   15. Wait 10 seconds; and    -   16. Repeat RF step 14 until entire wound has been covered with        energy and without laser.        Alternative RF and/or Laser Assisted Wounded Tissue Repair:    -   1. Optionally cleanse wound with saline;    -   2. Place any substrate or any combination of substrates onto or        into wound;    -   3. Direct RF/laser, RF, LED, or laser energy at wound for 1        minute or longer;    -   4. Place another layer of a chosen substrate or any combination        of substrates onto or into wound if necessary;    -   5. Wait 10 seconds;    -   6. Repeat steps 2-5 until wound bed is covered; and    -   7. Alternatively wait a specified period of time in between step        2-6.

Treatment of the oral cavity, head/neck, tongue, anal, vaginal regionand the deeper or surrounding areas reached while treating these may beperformed with the RF with substrate (applied substrate or drank withwater), RF without substrate, RF plus laser with substrate (appliedsubstrate or drank with water), RF plus laser without substrate andlaser with substrate (applied substrate or drank with water), laserwithout substrate. The treatment described may be utilized throughoutthe gastrointestinal tract, head/neck and anus. The laser, RF or LEDtreatment applied to the oral cavity and surrounding structures, analcavity and its surrounding structures, head and neck region and itssurrounding structures has benefits in deeper areas of the structures.Those deeper areas of the corresponding structures are thus part of thetreatment site. Surrounding structures include, but are not limited to,all bone, cartilage, muscles, tendons, nerves, blood vessels, epitheliumand fascia.

RF and/or Laser Assisted Head and Neck Wound Tissue Repair:

-   -   1. Optionally drink 4 oz. diluted Substrate 1;    -   2. Wait 15 minutes;    -   3. Optionally drink 4 oz. diluted Substrate 3;    -   4. Wait 15 minutes;    -   5. Direct RF/laser, RF or laser energy at head and neck location        and the surrounding structures where wound occurred;    -   6. Keep energy in place or move over desired area until desired        effect achieved; and    -   7. Move on to next site until desired result achieved.    -   8. Procedure can be started at Step 1 or Step 5.

Surrounding structures include, but are not limited to, all bone,cartilage, muscles, tendons, nerves, blood vessels, and epithelium.

Head and neck includes, but is not limited to, all structures of thehead and neck including esophagus and its surrounding structures, mouthincluding all interior mouth structures such as tongue (entire area oftongue including but not limited to anterior, posterior, dorsal,ventral, and sublingual), floor of mouth including but not limited toarterial and nerve beds, linea alba, buccal mucosa, buccal flanges,lingual flanges, nose, interior of nose (including but not limited tothe epithelial lining), all muscles and other structures of the tongueand surrounding the tongue, all muscles of the eye and surrounding theeye, all arterial, venous and nerve beds of the eye and surrounding theeye. All muscles, nerves, veins, all glands, soft and hard tissue of thehead and neck, and any other structure of the head and neck.

RF and/or Laser Assisted Vaginal Wound Repair:

1. Optionally drink 4 oz. diluted Substrate 1;

2. Wait 15 minutes;

3. Optionally drink 4 oz. diluted Substrate 2;

4. Wait 15 minutes;

5. Direct RF/laser, RF or laser energy at the vagina and its surroundingstructures;

6. Keep energy in place for 10-20 minutes or until desired effectachieved;

7. Rotate hand piece; and

8. Repeat steps 5-7 until desired result achieved.

9. Procedure can be started at Step 1 or Step 5.

Surrounding structures include, but are not limited to, all bone,cartilage, muscles, tendons, nerves, blood vessels, and epithelium.RF and/or Laser and/or LED Assisted Wound/Tissue Repair—Sphincter AniExternis:

-   -   1. Direct RF/laser, RF or laser energy at the anus and its        surrounding structures;    -   2. Keep energy in place until desired effect achieved;    -   3. Rotate hand piece if necessary    -   4. Repeat steps 1-4 until desired result achieved.

Surrounding structures include, but are not limited to, all bone,cartilage, muscles, tendons, nerves, blood vessels, and epithelium andany other structures of the anal cavity.

RF and/or Laser Assisted Wound Repair/Tissue Repair—Breast:

-   -   1. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5;    -   2. Wait 15 minutes;    -   3. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5;    -   4. Wait 15 minutes;    -   5. Direct RF/laser, RF or laser energy at the breast and        structures related to the breast;    -   6. Keep energy in place for 10-20 minutes or until desired        effect achieved;    -   7. Rotate hand piece; and    -   8. Repeat steps 5-7 until desired result achieved.    -   9. Procedure can be started at Step 1 or Step 5.        Related structures include, but are not limited to, all bone,        cartilage, muscles, tendons, nerves, blood vessels, lymph nodes        and epithelium.        RF and/or Laser Assisted Wound/Tissue Repair, Tongue and its        Supporting Structures in the Swallowing Mechanism:    -   1. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5;    -   2. Wait 15 minutes;    -   3. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5;    -   4. Wait 15 minutes;    -   5. Direct RF/laser, RF or laser energy at tongue and its        surrounding structures;    -   6. Keep energy in place for 10-20 minutes or until desired        effect achieved;    -   7. Rotate hand piece if necessary; and    -   8. Repeat steps 5-7 until desired result achieved.    -   9. Procedure can be started at Step 1 or Step 5.        Surrounding structures include, but are not limited to, all        bone, cartilage, muscles, tendons, nerves, blood vessels, and        epithelium.        RF and/or Laser Assisted Wound/Tissue Repair, Tongue and its        Supporting Structures in the Swallowing Mechanism:    -   1. Direct RF/laser, RF or laser energy at tongue and its        surrounding structures lingually, labially, sublingually,        pharyngeally or buccally;    -   2. Keep energy in place for until desired effect achieved;    -   3. Rotate hand piece if necessary; and    -   8. Repeat steps 1-3 until desired result achieved.

Surrounding structures include, but are not limited to, all bone,cartilage, muscles, tendons, nerves, blood vessels, and epithelium.

RF and/or Laser Assisted Wound Regeneration:

-   -   1. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5 and/or 6;    -   2. Wait 15 minutes;    -   3. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5 and/or 6;    -   4. Wait 15 minutes;    -   5. Optionally direct RF/laser, RF, LED or laser energy at wound        and its surrounding structures;    -   6. Apply or place Substrate 1, and/or 2, and/or 3, and/or 4,        and/or 5 and/or 6;    -   7. Optionally direct RF/laser, RF, LED or laser energy at wound        and its surrounding structures;    -   8. Keep energy in place for up to 10-20 minutes or until desired        effect achieved;    -   9. Rotate energy source if necessary; and    -   10. Repeat steps 5-9 until desired result achieved.    -   11. Alternatively wait a week in between steps 5-9 and gradually        cover wound bed.    -   12. Procedure can be started at Step 1 or Step 5.

Surrounding structures include, but are not limited to, all bone,cartilage, muscles, tendons, nerves, blood vessels, and epithelium.

RF and/or Laser Assisted Pore Repair:

-   -   1. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5;    -   2. Wait 15 minutes;    -   3. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5;    -   4. Wait 15 minutes;    -   5. Direct RF/laser, RF or laser energy at pores and their        surrounding structures;    -   6. Keep energy in place for 10-20 minutes or until desired        effect achieved;    -   7. Rotate hand piece; and    -   8. Repeat steps 5-7 until desired result achieved.    -   9. Procedure can be started at Step 1 or Step 5.

Surrounding structures include, but are not limited to, all bone,cartilage, muscles, tendons, nerves, blood vessels, and epithelium.

RF and/or Laser and/or LED Assisted Oral Cavity Wound Repair:

-   -   1. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5 and/or 6;    -   2. Wait 15 minutes;    -   3. Optionally drink 4 oz. diluted Substrate 1, and/or 2, and/or        3, and/or 4, and/or 5 and/or 6;    -   4. Wait 15 minutes;    -   5. Optionally direct RF/laser, RF or laser energy at oral cavity        and its' surrounding structures;    -   6. Optionally apply Substrate 1, and/or 2, and/or 3, and/or 4,        and/or 5 and/or 6;    -   7. Optionally direct RF/laser, RF, LED or laser energy wound and        its surrounding structures; 8. Keep energy in place for 10-20        minutes or until desired effect achieved;    -   9. Rotate energy source; and    -   8. Repeat steps 5-9 until desired result achieved.    -   9. Procedure can be started at Step 1 or Step 5.

Surrounding structures include, but are not limited to, all bone,cartilage, muscles, tendons, nerves, blood vessels, and epithelium.

Further still, wound treatment may be utilized for additional conditionsincluding, but not limited to, vaginal wound repair, breast woundrepair/regeneration/generation, anal wound repair, age spot repair, porerepair, skin and tissue repair and general body wound repair.

Referring to FIG. 33a-33e , shown is a fourth embodiment of a device 500for use in conjunction with the substrates and methods of the presentinvention. FIG. 33a shows a top view of the device 500 of the fourthembodiment. FIG. 33b shows a side view and FIG. 33c shows a close-up ofthe tip of device 500. Specifically, FIG. 33d illustrates an explodedview of the device 500 comprised of housing 503, tips 505 and energysource 507. Energy source 507 provides RF energy to housing 503 whenconnected. FIG. 33e shows a side perspective view of the assembleddevice 500. Optionally, the device 500 may be used in the absence ofsubstrates.

Referring to FIG. 34a-34f , shown is a fifth embodiment of a device 600for use in conjunction with the substrates and methods of the presentinvention. FIGS. 34d and 34f show side perspective views of device 600.FIG. 34a shows a side view of device 600 wherein device 600 has ahemispheric shape and is further comprised of a flat surface oppositethe hemispheric surface. The flat surface is further comprised of aplurality of mini lasers 605 for delivery of diode laser energy fortreatment of an acute wound. The mini lasers 605 are self-containedwithin device 600. In a preferred embodiment, the laser power used fortreatment may be approximately 6-24 mW.

Referring to FIG. 35a-35f , shown is power device 700 for a fiber optichad piece for use in conjunction with the substrates and methods of thepresent invention. FIG. 35a shows the components of pocket power device700, the pocket power device 700 further comprised of a base 701, abattery mount 702, a rechargeable battery 703, a handle for a fiberoptic laser 704, and a top 705. FIG. 35b-35f show various views of thepocket power device 700. The handle 704 is a self-contained unit havingan attached fiber optic line 706 upon which a fiber optic laser head(not shown) is connected. Further, a diode laser module is housed inpocket power device 700.

Referring to FIG. 36a-36f , shown is a portable RF transmitter 800 foruse in conjunction with the substrates and methods of the presentinvention. FIGS. 36e and 36f show side perspective views of RFtransmitter 800. FIG. 36a shows a top view; FIG. 36b shows front view;FIG. 36c shows a bottom view; and FIG. 36d shows a left side view.Optionally, the RF transmitter 800 may be used in the absence ofsubstrates.

Examples

I. Analysis of Tooth #15 at 12 Unique Loci

A patient's pocket depths at tooth 15 were measured at 12 separate loci.The root of the tooth was then scaled and planed to remove calculusbuild up on the root surface. After scaling and planning, bleedingoccurs in the sulcus. The sulcus was allowed to air dry and immediatelythereafter the conditioner is applied to the sulcus and left for 30seconds before being rinsed with saline. The tooth was next scaled andplaned again to renew blood flow. With blood pooling in the sulcus, the45° laser tip was placed into the sulcus. The laser light used has awavelength in the visible portion of the electromagnetic spectrum,between 400 nm-700 nm wavelength. The laser was emitted continuouslywith only intermittent stops for tissue temperature control. The laserwas allowed to penetrate the entire sulcus by moving the tip verticallyand horizontally throughout the sulcus for 30 second. The laser tip wascut to 45° in the opposite angle for the second pass into the sulcus and90° for the third pass to allow the laser bean to penetrate the existingperiodontium to decontaminate and biostimulate the sulcular contents.

In the meantime, the first substrate and the second substrate were mixedin a glass dish. Some of the patient's blood that has been treated withthe laser light in the sulcus was also mixed in the glass dish. Thismixture is then placed immediately into the sulcus upon mixture. Enoughof the mixture was placed into the sulcus to fill the sulcus whileensuring the mixture stayed 3 mm below the top of the gingival marginand remained immersed in blood. The patient's mouth was kept open for 5minutes to ensure the newly formed blood clot containing the substratemixture remained intact.

Treatment was repeated on tooth 15 on four subsequent occasions, atwhich time the pocket depths at each loci were measured prior totreatment. Measurements are shown in FIG. 11. The data show an increasein calcium density at the specific loci.

II. Analysis of Tooth #12 at 17 Unique Loci

A patient's pocket depths at tooth 28 were measured at 17 separate loci.The treatment disclosed herein was performed on five subsequentoccasions, at which time the pocket depths at each loci were measuredprior to treatment. Measurements are shown in FIG. 12. The data show anincrease in calcium density across all loci.

III. Analysis of Tooth #2, #3 and #15 at 3 Unique Loci Per Tooth

A patient's pocket depths at tooth 2, tooth 3 and tooth 15 were measuredat three separate loci per tooth. The treatment disclosed herein wasperformed 3 months after the initial treatment, at which time the pocketdepths at each loci were measured prior to treatment. Measurements areshown in FIG. 13. The data show a progression of bone generation.

IV. Analysis of Chin Profile

A patient's chin profile was measured. The treatment disclosed hereinwas performed once after the initial measurements were taken withmeasurements repeated following treatment. Measurements are shown inFIG. 24. The data show a general increase in chin profile following asingle treatment.

V. Analysis of Toe Crease

A patient's toe crease length was measured. The treatment disclosedherein was performed after initial measurements were obtained withmeasurements repeated following treatment. Measurements are shown inFIG. 25. The data show a 71% overall decrease in crease size followingtreatment.

VI. Analysis of Gingival Wound Tissue

A patient's gingival wounds were measured from the line to the top ofthe gingiva. The treatment disclosed herein was performed andmeasurements were repeated following treatment. Images of gingivalwounds are shown before and after treatment in FIGS. 26a and 26b .Measurements are shown in FIG. 26c . The data show a 50% or greaterdecrease in the wound following a single treatment.

VII. Analysis of Hand Crease

A patient's hand crease length was measured. The treatment disclosedherein was performed after initial measurements were taken withmeasurements repeated following treatment. Measurements are shown inFIG. 27. The data show an overall decrease in crease length followingtreatment.

VIII. Analysis of New Skin Growth

A patient's skin leg wound was measured. The treatment disclosed hereinwas performed after initial measurements were taken with measurementsrepeated following treatment. Measurements are shown in FIG. 28. Thedata show an overall increase in new skin growth following treatment. Ina preferred embodiment, chronic wounds on limbs may be treated using athree-sided LED system wherein the treatment unit is placed around thelimb on three sides and applies the LED energy to a larger surface area.The LED system uses an energy source less than 500 mW per LED unit oflight.

IX. Analysis of Anal Scar Reduction

A patient's anal scar tissue was measured. The treatment disclosedherein was performed after initial measurements were taken withmeasurements repeated following treatment. Measurements are shown inFIG. 29 and FIG. 30. The data show a reduction in both length and widthof scar tissue following treatment.

X. Analysis of Tongue Strength

Tongue strength and swallowing was assessed for three patients. Thetreatment disclosed herein was performed after initial assessments weremade and tongue strength and swallowing were reevaluated followingtreatment. Measurements are shown in FIG. 31. The data show each patientexperiencing an increase in tongue strength following treatment.

XI. Analysis of Breast Firmness

Breast firmness was recorded for two patients. The treatment disclosedherein was performed after initial assessments were made and breastfirmness was reevaluated following treatment. Comparative firmness isshown in FIG. 32. The data show the patients experiencing an increase infirmness of 75% and 66.7% following treatment, respectively.

XII. Analysis of Epithelial Wound Regeneration

The epithelial wound regeneration of a patient was assessed. Thetreatment disclosed herein was performed after initial wound measurementand wound size was remeasured following treatment. Comparativemeasurements are shown in FIG. 37. Epithelial regeneration was found tohave increased in area by 170% one day following treatment.

XIII. Analysis of Calcaneal Tendon Wound Regeneration

The calcaneal tendon wound regeneration of a patient was assessed. Thetreatment disclosed herein was performed after initial wound measurementand wound size was remeasured following treatment. Comparativemeasurements are shown in FIG. 38. Tendon shelf size increased fourtimes from the initial measurement to the third and final measurement.

XIII. Analysis of Ankle Epithelial Wound Regeneration

The ankle epithelial wound regeneration of a patient was assessed. Thetreatment disclosed herein was performed after initial wound measurementand wound size was remeasured following treatment. Comparativemeasurements for two treatment areas are shown in FIG. 39. Epithelialregeneration was found to have increased in area by 264% five monthsfollowing treatment.

XIV. Analysis of Ankle Wound Size Reduction

The ankle epithelial wound size reduction of a patient was assessed. Thetreatment disclosed herein was performed after initial wound measurementand wound size was remeasured following treatment. Comparativemeasurements for two treatment areas are shown in FIG. 40. Epithelialwound size was found to have decreased in area by 72% five monthsfollowing treatment.

XV. Analysis of Oral Cavity Wound Regeneration

The oral cavity epithelial wound regeneration of a patient was assessed.The treatment disclosed herein was performed after initial woundmeasurement and wound size was remeasured following treatment.Comparative measurements are shown in FIG. 41. Epithelial regenerationsize increased by 1.34 cm² from the initial measurement to the fourthand final measurement.

XVI. Analysis of Vein Wound Regeneration

The vein wound regeneration of a patient was assessed. The treatmentdisclosed herein was performed after initial wound measurement and woundsize was remeasured following treatment. Comparative measurements areshown in FIG. 42a . Epithelial regeneration size increased by 2.9 cm²from the initial measurement to final measurement. Treatment wasconducted using a flashlight style infrared laser as shown in FIG. 42bwherein the LED beam is a concentrated flat line of light applied to theskin and veins. The flashlight style laser is a self-contained modularlaser that allows for manipulation of skin around a wound duringtreatment. Alternatively, a LED panel may be used.

XVII. Analysis of Tissue Regeneration

The wound regeneration of a patient was assessed and comparativemeasurements are shown at FIG. 43a . The wound was to epithelial tissueand the extent of the wound was first measured having an impacted lengthof 7.70 cm², a width of 2.20 cm² and an overall area of 2.42 cm². Sixweeks later, the extent of the patient's wound was substantially reducedto a length of 0.8 cm², a width of 0.7 cm² and an overall area of 0.06cm². Another patient was assessed with a wound in the oral cavity, withresults detailed at FIG. 43b . As a measurement of new tissueregenerated, over a four day period, the patient exhibited a significantamount of increased skin area of regenerated tissue, starting with zeroregeneration at day zero up to 1.34 cm² four days later.

One embodiment of the present invention provides a device for treating awound according to the method described herein, the device emitting alaser a beam of light having a wavelength in the green wavelength range(520-570 nm), red wavelength range (620-750 nm), or yellow wavelengthrange (570-590 nm) having an alternative wattage of 0.001 W to 5 W,preferably 0.002 W to 4 W, more preferably 0.003 W to 3 W, and mostpreferably 0.005 W to 2 W. Optionally, the laser light utilizes the IRwavelength range (700 nm-1400 nm) at a laser power of 0.001 W to 5 W totreat wounds. Optionally, a LED light utilizes the IR wavelength rangeto treat wounds.

Another embodiment of the present invention provides a device fortreating a wound according to the method described herein, the deviceemitting a RF beam up to 10 W or, preferably, 9 W comprised of a carrierwave frequency in the range of 0.1 MHz to 20 MHz and a non-sinusoidalwaveform in the range of 0.5 to 40 KHz. In a preferred embodiment, thecarrier wave frequency is in the range of 0.2 MHz to 10 MHz, preferably0.3 MHz to 5 MHz. Optionally a 0.001 W to 10 W range RF energy,preferably a 0.001 W to 3 W range, is utilized in the hertz range of 40Hz to 24 GHz. In a further alternative embodiment, the RF wave is morethan one sine wave wherein the more than one demonstrates a harmonicspattern. Optionally, the non-sinusoidal waveform may be in the range ofthe above parameters as single or multiple waveforms in the presence orabsence of a carrier wave.

Yet another embodiment of the present invention provides a device fortreatment of a wound according to the method described herein, thedevice emitting a laser beam, a LED beam of light, a RF beam or acombination thereof.

Still another embodiment of the present invention provides a device fortreatment of wounds in the oral cavity according to the method describedherein, the device emitting a fiber optic laser beam. In a preferredembodiment, the fiber optic device may be used in conjunction with thelaser, and/or RF device for treating general wounds and wounds of theoral cavity. Optionally, the device emits a LED light. Optionally morethan one fiber can be in the handpiece and each fiber can be of adifferent wavelength and different average power.

While there have been shown and described and pointed out thefundamental novel features of the invention as applied to the preferredembodiments, it will be understood that the foregoing is considered asillustrative only of the principles of the invention and not intended tobe exhaustive or to limit the invention to the precise forms disclosed.

Obvious modifications or variations are possible considering the aboveteachings. The embodiments discussed were chosen and described toprovide the best illustration of the principles of the invention and itspractical application to enable one of ordinary skill in the art toutilize the invention in various embodiments and with variousmodifications as are suited to the particular use contemplated All suchmodifications and variations are within the scope of the invention asdetermined by the appended claims when interpreted in accordance withthe breadth to which they are entitled.

What is claimed is:
 1. A method of treating damage to a tissue in theform of an acute or chronic wound, comprising: (a) providing aninstrument comprising a hand piece or light panel, further comprising atleast one opening through which a diode laser or a light emitting diode(LED) is positioned, the diode laser or LED generating a beam of lighthaving a wavelength from about 400 nm to about 1400 nm, wherein the beamof light exits the instrument through the at least one opening; (b)providing a power source to operate the instrument; and (c) positioningthe at least one opening from the hand piece or light panel of theinstrument directly or in close proximity to the damage to the tissue ofan individual.
 2. The method of claim 1, wherein the beam of light has awavelength selected from the group consisting of from about 520 nm toabout 570 nm, from about 620 nm to about 750 nm and from about 570 nm toabout 590 nm, further wherein the power source transmits a range ofpower from about 0.0001 W to about 5 W to the instrument.
 3. The methodof claim 4, wherein the power source transmits a range of power selectedfrom the group consisting of from about 0.002 W to about 4 W, from about0.003 W to about 3 W and from about 0.005 W to about 2 W to theinstrument.
 4. A device for the treatment of wounds on or in anindividual, the device having at least a first energy source capable ofbiostimulating soft and hard tissue, wherein the device has a handpieceand the first energy source is a radiofrequency (RF) waveform having awattage of less than 9 W.
 5. The device of claim 4, further comprising asecond energy source, wherein the second energy source comprises a laserlight having a wavelength in the visible portion of the electromagneticspectrum between 400 nm-700 nm wavelength.
 6. The device of claim 5,wherein the wavelength is selected from the group consisting of thegreen wavelength range (520-570 nm), the red wavelength range (620-750nm) and yellow wavelength range (570-590 nm).
 7. The device of claim 5,wherein the laser has a wattage selected from the group consisting of0.003 W to 3 W and 0.005 to 2 W.
 8. The device of claim 4, wherein thewaveform is comprised of a sine carrier wave having a frequency in therange selected from the group consisting of 0.1 MHz to 20 MHz, 0.2 MHzto 10 MHz, and 0.3 MHz to 5 MHz, and a non-sinusoidal waveform having afrequency in the range of 0.5 Hz to 24 GHz.
 9. The device of claim 4,wherein the RF wave is more than one square wave and is capable ofdemonstrating a pattern.
 10. The device of claim 4, wherein the RF waveis more than one sine wave and is capable of demonstrating a harmonicspattern.
 11. The device of claim 4, wherein a second energy source isfiber optic.
 12. The device of claim 4, further comprising a substratecomprised of: sodium chloride in solution with a sodium content of 1.1mg/100 g, 60% water, 9% lysine, 9% proline, 9% of additional amino acidsselected from the group consisting of isoleucine, leucine, methionine,phenylalanine, threonine, tryptophan, valine, histadine and lysine, 2%of all other non-essential amino acids wherein the amino acids arechosen from the group consisting of alanine, arginine, aspartate,glutamate, glycine, serine and proline, 6.9% free bases wherein the freebases are chosen from the group consisting of adenosine, uridine,guanosine, iridine and cytidine, 2% phosphates wherein the phosphatesare chosen from the group consisting of ADP, ATP and acetylcholine and1% benzoic acid.
 13. The device of claim 4, further including asubstrate comprised of collagen limed, collagen unlimed or collagensupplemented with dense or porous tricalcium phosphate crystals.
 14. Thedevice of claim 12, wherein the substrate comprises a total sterilewater component that is adjusted up or down by about 20% in order toachieve a preferred viscosity.
 15. The device of claim 12, wherein thesubstrate comprises a total sterile water component that is adjusted upor down by about 20% and that may contain an effective amount ofhyaluronic acid.
 16. A system for use in decontaminating and healingtissue comprising: (a) an instrument comprising a hand piece with atleast one tip, through which a radiofrequency (RF) wave is transmitted;and (b) a power source to operate the instrument; wherein the at leastone tip from the hand piece of the instrument is positioned directly orin close proximity to the tissue of an individual.
 17. A substrate foruse in treating soft tissue damage, comprising: (a) at least one ofcollagen limed and collagen unlimed; and (b) an effective amount of HClor NaCl
 18. The substrate of claim 17, further comprising at least onenanoparticle, the at least one nanoparticle is selected from the groupconsisting of copper, gold, silver, iron, Fe₃O₄ and platinum, or anycombination thereof and/or at least one additional compound selectedfrom the group consisting of CuCl₃, CuCl₂, CuCl, FeCl₃, FeCl₂, AuCl,AuCl₂, AuCl₂, AgCl, AgCl₂ and hyaluronic acid, and any combinationthereof.
 19. The substrate of claim 17, further comprising an effectiveamount of tricalcium phosphate or dense or porous hydroxyapatite in avariety of crystal sizes.
 20. A system for use in repairing tissuedamage subsequent to an acute or chronic injury to an individualcomprising: (a) a device comprising a light or radio frequency energysource with at least one opening or tip, through which the light orradio frequency energy source can emit a beam of light or a radiofrequency wave, further wherein the instrument is connected to a powersource; (b) at least one substrate, wherein the substrate is capable ofinducing a biostimulatory response when applied to the tissue damage,wherein the beam of light or radio frequency wave is placed over thetissue damage and the at least one substrate is applied directly to orinto the tissue damage.